The invention relates to a plastic needle. It also relates to a syringe and a recipient connector comprising said plastic needle.
Pyrogens or pyrogenic substances are impurities which, where present in a pharmaceutical product intended for being administered to a patient, cause a fever reaction when the pharmaceutical product is actually administered.
In the medical field, numerous devices comprise needles for injection and/or perforation which enable the flow of a pharmaceutical product, generally a liquid.
Such needles intended for containing and transporting a pharmaceutical product must not only be sterile and sterilizable, but also apyrogenic, i.e. they contain no pyrogens, and must be depyrogenisable, i.e. they must be capable of undergoing a process which removes any pyrogens which they may contain.
In fact, in order to depyrogenise such needles, they have to be heated up to 253° C. for one hour.
This is one of the reasons why needles for injection of a pharmaceutical product into human tissue are generally made of metal. Another reason is that these needles for injection into human tissue have to be very fine in order to limit the pain experienced by the patient, whilst retaining adequate strength and rigidity for penetration of the skin and the subcutaneous layers.
However, metal needles, once they have been used, cannot be easily disposed of, and this gives rise to a sanitary health problem because of contamination accidents arising from contact with (or accidental re-utilization of) these non-sterilized and non-depyrogenised needles
In order to solve this problem of needles for injection of pharmaceutical products, particularly into the human body, needles made of plastic have been proposed.
In particular, international patent application WO 00/72901 describes a process for the manufacture of such a plastic injection needle in which the employed plastic is a liquid crystalline polymer comprising 73% hydroxy benzoic acid and 27% hydroxy naphthoic acid.
However, plastic needles of the prior art cannot be heated up to 253° C. for one hour without becoming deformed.
In reality, where a plastic needle for use in the medical field is employed, it is for single use only and it cannot be depyrogenised, but is manufactured under conditions such that it is free of pyrogens. However, once it has been taken out from its pack and utilized, it is not depyrogenisable.
Furthermore, since these needles are not depyrogenisable, it is not possible, not even before first utilization, to depyrogenise them in order to be certain that they are indeed free of pyrogens. Indeed, production problems or problems occurring during their transport or handling may have caused contamination with pyrogens.
Needles are also employed as a means for perforation and flow of a product contained in a recipient to a different recipient, interconnected by a recipient or bottle connector.
A bottle connector of this type is generally made up of a first hollow section intended for fitting around the neck of a first recipient and a second hollow section intended for fitting into the neck of a second recipient, such hollow sections being separated from each other by a horizontal wall at the center of which there is a means of perforation, elastic capsules of the recipients to be connected together, and a passage for flow of products, generally liquid, contained in one bottle towards the other bottle.
This means of perforation and of inducing flow may be a needle similar to an injection needle but with larger internal and external sections.
Again, with regard to bottles containing pharmaceutical products, for example for transfusion to a human being, it is important to assure the sterility and absence of pyrogens at least in the materials making up the needle which is used for perforation and flow.
Accordingly, in these needles of connectors of the prior art, we encounter the same problems as in respect of the above described injection needles.